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AESCULAP
Model PM438R · Aesculap AG · DI 04038653322862
GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400
HGI — Electrocautery, Gynecologic (And Accessories) · Class II · 21 CFR 884.4120
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (97)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 58 · Injury: 39
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
2
6.66
2019-02
2
4.26
2019-03
0
4.33
2019-04
0
5.9
2019-05
2
4.7
2019-06
0
4.86
2019-07
0
5.77
2019-08
4
5.99
2019-09
0
4.96
2019-10
2
5.86
2019-11
2
5.56
2019-12
2
5.26
2020-01
2
4.77
2020-02
0
5.43
2020-03
2
5.59
2020-04
0
3.51
2020-05
0
3.68
2020-06
0
5.04
2020-07
0
6.43
2020-08
0
4.57
2020-09
0
5.81
2020-10
0
5.48
2020-11
9
5.05
2020-12
2
5.19
2021-01
4
5.08
2021-02
2
4.87
2021-03
2
5.63
2021-04
0
5.21
2021-05
11
5.23
2021-06
0
5.82
2021-07
5
4.91
2021-08
0
4.28
2021-09
0
4.77
2021-10
0
6.36
2021-11
0
5.57
2021-12
6
5.73
2022-01
0
4.9
2022-02
0
5.15
2022-03
0
5.78
2022-04
0
4.96
2022-05
0
5.87
2022-06
0
6.49
2022-07
6
4.5
2022-08
4
4.8
2022-09
0
4.93
2022-10
0
4.88
2022-11
0
4.77
2022-12
0
4.07
2023-01
0
5.57
2023-02
0
4.69
2023-03
4
4.9
2023-04
0
4.75
2023-05
2
5.2
2023-06
2
4.81
2023-07
2
4.73
2023-08
2
4.49
2023-09
0
5.17
2023-10
0
5.11
2023-11
0
4.34
2023-12
0
4.77
2024-01
2
5.48
2024-02
0
5.41
2024-03
2
5.98
2024-04
2
5.98
2024-05
0
6.21
2024-06
0
5.24
2024-07
0
5.02
2024-08
0
4.93
2024-09
0
5.13
2024-10
0
5.6
2024-11
0
5.24
2024-12
0
4.01
2025-01
0
5.11
2025-02
2
4.44
2025-03
0
6.2
2025-04
0
4.41
2025-05
2
5.15
2025-06
0
5
2025-07
0
5.17
2025-08
0
5.41
2025-09
0
4.79
2025-10
0
5.13
2025-11
0
5.57
2025-12
0
5.77
2026-01
0
5.56
2026-02
0
5.92
2026-03
0
6.14
2026-04
0
5.41
2026-05
0
6.19
2026-06
4
5.58
This device (reports/month)Average device in GEI, HGI (reports/device/month)